Navigating The New EU Clinical Trial Framework

ACT: As the deadline for legal transition for EU clinical trials approaches, what strategies can companies deploy to smoothly navigate the shift from the old framework to the CTR?

Neuberger: The clinical trial regulation provided a three-year transition period for ongoing EU clinical trials that were approved under the old framework. Now, they must move to the clinical trial regulation. That period expires on January 31st, 2025. The biggest challenge for sponsors is getting the study transition ready and also getting a transition done in the little time that remains. Basically, strategic planning is key, and from our perspective, there’s two key steps. The first is harmonization of the core dossier. And then also, it’s the administrative setup of cities.

You have the two parts of your documentation. First is the core documentation, your protocol, your IB, and your IMPD. Those need to be harmonized so you only have one set of documentation. Under the directive, you could have ended up with 27 sets of documentation. So as a rule of thumb, something like general study design, population or a scientific evaluation needs to be harmonized, and this harmonization you are achieving by submitting substantial amendments under the old framework to the individual health authorities. Minor changes such as local adaptations of the of the protocol can be done with consolidation. They don't have to be submitted to the health authorities. Also, the local documentation that goes into part two doesn't have to be submitted for approval under the old framework.

It’s important to note here that all regulatory processes and the old framework, the directive, all the harmonization procedures have to be finalized before you can transition. Trial and health authorities are pretty stretched at the moment because they are, in effect, working in two frameworks. They have the new framework for all the trials, and they also have the old ongoing trials. So, timelines can basically shift. and we have frequently seen that health authorities take a lot longer for the approval of substantial amendments. Once you have achieved your harmonized documentation, you can then submit the transition of a clinical trial. Regulators encourage all sponsors to use the expedited process even though they say it could still take the whole 106 days. However, even with the expedited process and taking everything into account, the deadline for submission of the transition of a clinical trial will be the 16th of October. That is very close, and I think this is one of the biggest challenges.